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Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-52)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02335424
First Posted: January 9, 2015
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants, in participants whose tumors rely on programmed cell death ligand 1 (PD-L1) protein (PD-L1-positive tumors), and in participants with strongly PD-L1-positive tumors.

Condition Intervention Phase
Urothelial Cancer Biological: pembrolizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for All Participants (Independent Radiology Review) [ Time Frame: Up to 3 years ]
  • ORR by RECIST 1.1 for Participants with PD-L1-positive Tumors (Independent Radiology Review) [ Time Frame: Up to 3 years ]
  • ORR by RECIST 1.1 for Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures:
  • Duration of Response (DOR) by RECIST 1.1 for All Participants, Participants with PD-L1-positive Tumors and Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review) [ Time Frame: Up to 3 years ]
  • Progression-free Survival (PFS) by RECIST 1.1 for All Participants, Participants with PD-L1-positive Tumors and Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review) [ Time Frame: Up to 3 years ]
  • Overall Survival (OS) for All Participants, Participants with PD-L1-positive Tumors and Participants with Strongly PD-L1-positive Tumors [ Time Frame: Up to 3 years ]

Other Outcome Measures:
  • ORR by Modified RECIST 1.1 in All Participants (Independent Radiology Review) [ Time Frame: Up to 3 years ]
  • ORR by Modified RECIST 1.1 in Participants with PD-L1-positive Tumors (Independent Radiology Review) [ Time Frame: Up to 3 years ]
  • ORR by Modified RECIST 1.1 in Participants with Strongly PD-L1-positive Tumors (Independent Radiology Review) [ Time Frame: Up to 3 years ]

Estimated Enrollment: 350
Actual Study Start Date: February 24, 2015
Estimated Study Completion Date: June 21, 2018
Estimated Primary Completion Date: June 21, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab, 200 mg intravenous (IV) on Day 1 of each 3-week cycle for up to 24 months
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

Detailed Description:
Participants receiving pembrolizumab who attain a complete response (CR) may consider stopping trial treatment if they meet criteria for holding therapy. Participants who stop trial treatment after receiving 24 months of trial treatment for reasons other than progressive disease (PD) or intolerability, or participants who attain a CR and stop trial treatment may be eligible for up to one year of retreatment upon experiencing PD.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically- or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies)
  • Ineligible for cisplatin therapy
  • No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed)
  • Available tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Measureable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate organ function
  • Female participants of childbearing potential have a negative urine or serum pregnancy test; surgically sterile, or willing to use 2 acceptable methods of birth control, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
  • Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment

Exclusion Criteria:

  • Disease that is suitable for local therapy administered with curative intent
  • Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment
  • Prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to a previously administered agent
  • Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • Evidence of interstitial lung disease or active non-infectious pneumonitis
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor
  • Known human immunodeficiency virus (HIV)
  • Known active Hepatitis B or C
  • Received a live virus vaccine within 30 days of planned start of study treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335424


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02335424     History of Changes
Other Study ID Numbers: 3475-052
2014-002206-20 ( EudraCT Number )
First Submitted: January 7, 2015
First Posted: January 9, 2015
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Merck Sharp & Dohme Corp.:
P-D1
PD-1
PD1
P-DL1
PD-L1
PDL-1
PDL1
Bladder cancer

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents